Carotenoids are a class of hydrocarbons consisting of isoprenoid units joined in such a manner that their arrangement is reversed at the center of the molecule. The backbone (skeleton) of the molecule consists of conjugated carbon-carbon double and single bonds, and can also have pendant groups. Although it was once thought that the skeleton of a carotenoid contained 40 carbons, it has been long recognized that carotenoids can also have carbon skeletons containing fewer than 40 carbon atoms. The 4 single bonds that surround a carbon-carbon double bond all lie in the same plane. If the pendant groups are on the same side of the carbon-carbon double bond, the groups are designated as cis; if they are on opposite sides of the carbon-carbon bond, they are designated as trans. Because of the large number of double bonds, there are extensive possibilities for geometrical (cis/trans) isomerism of carotenoids, and isomerization occurs readily in solution. A series of books which is an excellent reference to many of the properties, etc. of carotenoids (“Carotenoids”, edited by G. Britton, S. Liaaen-Jensen and H. Pfander, Birkhauser Verlag, Basel, 1995 hereby incorporated by reference in its entirety).
Many carotenoids are nonpolar and, thus, are insoluble in water. These compounds are extremely hydrophobic which makes their formulation for biological uses difficult because, in order to solubilize them, one must use an organic solvent rather than an aqueous solvent. Other carotenoids are monopolar, and have characteristics of surfactants (a hydrophobic portion and a hydrophilic polar group). As such, these compounds are attracted to the surface of an aqueous solution rather than dissolving in the bulk liquid. A few natural bipolar carotenoid compounds exist, and these compounds contain a central hydrophobic portion as well as two polar groups, one on each end of the molecule. It has been reported (“Carotenoids”, Vol. 1A, p. 283) that carotenoid sulphates have “significant solubility in water of up to 0.4 mg/ml”. Other carotenoids that might be thought of as bipolar are also not very soluble in water. These include dialdehydes and diketones. A di-pyridine salt of crocetin has also been reported, but its solubility in water is less than 1 mg/ml at room temperature. Other examples of bipolar carotenoids are crocetin and crocin (both found in the spice saffron). However, crocetin is only sparingly soluble in water. In fact, of all of the natural bipolar carotenoids, only crocin displays significant solubility in water.
U.S. Pat. Nos. 4,176,179; 4,070,460; 4,046,880; 4,038,144; 4,009,270; 3,975,519; 3,965,261; 3,853,933; and 3,788,468 (each of which is hereby incorporated by reference in its entirety) relate to various uses of crocetin.
U.S. Pat. No. 6,060,511, relates to trans sodium crocetinate (TSC) and its uses. The TSC is made by reacting naturally occurring saffron with sodium hydroxide followed by extractions. The '511 patent covers an extraction method for making a bipolar trans carotenoid salt (Trans Sodium Crocetinate), a purified composition obtained from extraction, and various uses of the composition such as improving oxygen diffusivity and treatment of hemorrhagic shock.
PCT Application US03/05521 relates to the chemical synthesis method for making bipolar trans carotenoid salts, and methods of using them.
The figure below shows the last few steps of a chemical synthesis process for TSC described in PCT Application US03/05521.

The complete synthesis procedure for TSC, as described in the PCT application, arrived at key intermediates, “Compound A” and “Compound B” via multi-step synthetic processes shown in the two figures below:

A common form of therapy for malignant tumors, or cancer, is irradiation. The radiation administered is in the form of electromagnetic waves or charged or neutral particles. Electromagnetic waves are represented by x-rays or gamma rays. Charged particles take the form of electrons, protons, or heavy ions, while neutrons are an example of neutral particles. During a course of therapy, the radiation may be administered by external beam, an interstitial implant, or a combination of the two. With irradiation, the rad and Gray are the usual units of measure. A dose of one rad for any type of radiation results in the absorption of 100 ergs of energy per gram of target tissue, and one Gray is equal to 100 rads. Therefore, one centiGray (cGy) is equivalent to one rad. For the majority of smaller tumors of the head and neck, a course of radiotherapy consisting of 6000 to 6500 cGy over 6 to 6.5 weeks is usually adequate. Doses of 6500 to 700 cGy over 6.5 to 7.5 weeks may be necessary to control larger masses with even higher doses required for bulky disease. It has been shown that a dose of 5000 cGy over 5 weeks will control subclinical disease in 90 to 95% of patients.
A viable tumor cell is one in which the capacity for unlimited division is present. A tumor cell must lose this reproductive capability to be considered killed. Radiotherapeutic tumor control is achieved by the elimination of all viable cells within a tumor, and a given dose of radiation will result in the death of a certain proportion (not number) of viable cells with each administration. Therefore, the larger the volume of tumor, the larger the total dose of radiation required for tumor control. A tumor cell which has been sterilized or killed with radiotherapy may not necessarily have been morphologically altered and typically manifests cell death at the time of mitosis (cell division). It is important to note that this death may not occur with the first cell division following irradiation. Several apparently successful cell cycles may take place before cell death becomes overtly manifest, but the cell is still considered no longer viable in that its unlimited reproductive potential has already been lost.
The radiosensitivity of tumor cells is influenced by many factors. Not long ago, tumor histology and location were thought to play major roles in the potential control of tumors with radiotherapy. There is no doubt that certain tumors are more difficult to control with radiotherapy, but histology is no longer felt to be as important. The number of viable tumor cells and the proportion of hypoxic (lacking oxygen) cells within a tumor are major contributors to radiosensitivity, and both of these are a function of the size of a given tumor.
It has been apparent for many years that oxygen plays an important role in tumor sensitivity to radiation therapy. That hypoxic tumor cells are more radioresistant is well-established. While the mechanism for this phenomenon is incompletely understood, the presence of oxygen is thought to fix radiation injury within cells which is labile and would otherwise have been repaired. The maximum change in radiosensitivity occurs over the range of 0-20 mm of Hg, a value which is well below the venous oxygen tension. Significant hypoxia has been demonstrated in experimental solid tumors, and significant indirect evidence indicates hypoxic conditions within human tumors as well. Hypoxic conditions may develop because tumors often outgrow their existing blood supply. Chemotherapy is another method used to treat cancer. Drugs are administered, such carmustine (BCNU), temozolamide (TMZ), cisplatin, methotrexate, etc., and these drugs will result in the eventual death or non-growth of the tumor cells. It has been noted that chemotherapy, like radiation therapy, is less successful with hypoxic cells—which frequently occur in tumors.
High blood pressure, or hypertension, affects about one in four Americans. This potentially life-threatening condition can exist virtually without symptoms. Blood pressure is characterized by two values: the systolic blood pressure and the diastolic blood pressure. Hypertension is generally defined at a systolic pressure above 140 mm Hg or a diastolic pressure greater than 90 mm Hg; however, these definitions change and some physicians feel that blood pressure should remain at 120/70 all one's life, either naturally or with the use of antihypertensive medicine.
In some people, the system that regulates blood pressure goes awry: arterioles throughout the body stay constricted, driving up the pressure in the larger blood vessels. Sustained high blood pressure—above 140/90 mm Hg, according to most experts—is called hypertension. About 90 percent of all people with high blood pressure have what is currently called “essential” hypertension—which is meant to denote that it has no identifiable cause. In the remaining 10 percent of cases, the elevated blood pressure is due to kidney disease, diabetes, or another underlying disorder.